Study to Assess the Efficacy & Safety of KHK4951 in Patients With Diabetic Macular Edema

Part of paid clinical trials in Mesa, Arizona.

Sponsor
Kyowa Kirin Co., Ltd.
Study ID
NCT06116916
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Diabetic Macular Edema (DME)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • KHK4951 — DRUG
    KHK4951 eye drop for 36 weeks until end of the trial
  • Aflibercept Injection — DRUG
    Intravitreal injection (IVT) of aflibercept will be given as specified in the protocol

Study Details

The purpose of this study is to evaluate efficacy and safety of KHK4951 eye drops in patients with DME.

Key Dates

Start date
Jan 9, 2024
Status verified
Oct 2025
Primary completion
Aug 31, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    KHK4951 High dose
  • Experimental: Arm B
    KHK4951 Middle dose
  • Experimental: Arm C
    KHK4951 Low dose

Primary Outcome Measure

Reduction of 15 or more letters in BCVA (Best corrected visual acuity) as measured by ETDRS visual acuity chart from baseline [ Time Frame: For 36 weeks until the end of the trial ]

Locations (40)

FacilityCityStateZIPSite coordinators
Barnet Dulaney Perkins Eye Center - PhoenixMesaArizona85206-
Retina Associates Southwest, P.C.TucsonArizona85710-
Win RetinaArcadiaCalifornia91006-
Retina Vitreous Associates Medical GroupBeverly HillsCalifornia90211-
The Retina PartnersEncinoCalifornia91436-
Salehi Retina Institute, IncHuntington BeachCalifornia92647-
California Eye Specialists Medical Group IncPasadenaCalifornia91107-
Retina Consultants of Southern CaliforniaRedlandsCalifornia92374-
Retina Consultants of Southern COColorado SpringsColorado80909-
Blue Ocean Clinical Research WestClearwaterFlorida33761-
Florida Eye AssociatesMelbourneFlorida32901-
Eye Associates of PinellasPinellas ParkFlorida33782-
Ft. Lauderdale Eye InstitutePlantationFlorida33324-
Retina Vitreous Associates of Florida - Saint PetersburgSt. PetersburgFlorida33711-
Southern Vitreoretinal AssociatesTallahasseeFlorida32308-
Center for Retina and Macular Disease - OphthalmologyWinter HavenFlorida33880-
Mid Atlantic Retina Specialists - HagerstownHagerstownMaryland21740-
Sierra Eye AssociatesRenoNevada89502-
Envision Ocular, LLCBloomfieldNew Jersey07003-
Vision Research Center Eye Associates of New MexicoAlbuquerqueNew Mexico87109-
Retina Vitreous Surgeons of Central NY, PCLiverpoolNew York13088-
Ophthalmic Consultants of Long IslandOceansideNew York11572-
Retina Vitreous Center in Edmond OklahomaEdmondOklahoma73013-
EyeHealth NorthwestPortlandOregon97225-
Wills Eye Health SystemBethlehemPennsylvania18017-
Eye Care SpecialistsKingstonPennsylvania18704-
Retina Consultants of Charleston - (RCA Network Site)CharlestonSouth Carolina29414-
Charleston Neuroscience Institute (RCA Network Site)LadsonSouth Carolina29456-
Black Hills Regional Eye Institute - OphthalmologyRapid CitySouth Dakota57701-
Charles Retina InstituteGermantownTennessee38138-
Retina Research Institute of TexasAbileneTexas79606-
Austin Clinical Research, LLCAustinTexas78750-
Austin Retina Associates - Ophthalmology/Retina (RCA Network site)AustinTexas78705-
Retina Consultants of TexasBellaireTexas77401-
Texas Retina AssociatesFort WorthTexas76104-
Retinal Consultants of Texas- San Antonio (RCA Network site)San AntonioTexas78240-
Retina Consultants of Texas (RCA Network Site)The WoodlandsTexas77384-
Strategic Clinical Research Group, LLCWillow ParkTexas76087-
University of Vermont Fletcher Allen Health CareBurlingtonVermont05401-
Retina Group of WashingtonFairfaxVirginia22031-

Find similar trials in Mesa, AZ

By research site
Barnet Dulaney Perkins Eye Center - Phoenix· Mesa, AZRetina Associates Southwest, P.C.· Tucson, AZWin Retina· Arcadia, CARetina Vitreous Associates Medical Group· Beverly Hills, CAThe Retina Partners· Encino, CASalehi Retina Institute, Inc· Huntington Beach, CA

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